Global Regulatory Affairs Leader — Medical Devices

Werfen is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory and quality system support for U.S., Canada, and EU product lines. You will coordinate submissions (510(k), BLA, and device licenses) and maintain technical documentation, ensuring compliance with SOPs and global standards.

The role requires at least eight years of regulatory affairs experience in medical devices and strong knowledge of design controls, FDA regulations, and EU MDR/IVDR.